U.S. patent number 6,629,602 [Application Number 09/716,619] was granted by the patent office on 2003-10-07 for clear medical packaging.
This patent grant is currently assigned to Becton, Dickinson and Company, Becton, Dickinson and Company. Invention is credited to Peter W. Heyman.
United States Patent |
6,629,602 |
Heyman |
October 7, 2003 |
Clear medical packaging
Abstract
A medical package has a tub and a lid. The tub has a four-sided
base with walls extending upwards therefrom; the walls terminate at
a first flange with extends outwardly. From the first flange, four
top walls extend upward and terminate at a second flange which
extends outwardly. The tub is formed of a clear, ultraviolet light
transmitting plastic. The lid has a gas permeable, microfiber
central portion surrounded by a clear, ultraviolet light
transmitting plastic film. The film has a high shear resistance and
does not produce particulate matter during an opening
procedure.
Inventors: |
Heyman; Peter W. (Berkeley
Heights, NJ) |
Assignee: |
Becton, Dickinson and Company
(Franklin Lakes, NJ)
|
Family
ID: |
28455195 |
Appl.
No.: |
09/716,619 |
Filed: |
November 20, 2000 |
Current U.S.
Class: |
206/438; 206/366;
206/484.1 |
Current CPC
Class: |
A61L
2/07 (20130101); A61L 2/10 (20130101); A61L
2/206 (20130101); A61L 2/26 (20130101); A61B
50/30 (20160201); A61L 2202/182 (20130101); A61L
2202/24 (20130101); A61B 2050/0065 (20160201); A61B
2050/3015 (20160201) |
Current International
Class: |
A61B
19/02 (20060101); A61B 19/00 (20060101); A61L
2/04 (20060101); A61L 2/20 (20060101); A61L
2/07 (20060101); A61L 2/26 (20060101); A61L
2/10 (20060101); B65D 77/20 (20060101); B65D
77/10 (20060101); A61B 017/06 () |
Field of
Search: |
;206/438,439,363,364,365,366,484.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Luong; Shian
Attorney, Agent or Firm: DeGrazia; Gregory D. Fortunato;
David M.
Claims
What is claimed is:
1. A medical device package for containing a medical device, the
package enabling sterilization of the medical device within the
package and maintaining the medical device in a sterilized
condition within the package, the package comprising: a tub having
a four-sided base and being formed of a clear, ultraviolet light
transmitting plastic capable of withstanding exposure to steam and
ethyleneoxide sterilization environments without degradation of
said tub, the tub having four walls intersecting the base and
extending upwardly therefrom and terminating at a first outwardly
extending flange which extends laterally from the four walls; the
first outwardly extending flange terminating at four top walls that
extend from the first outwardly extending flange at approximately
ninety degrees and terminating at a second outwardly extending
flange that extends from the four top walls at approximately ninety
degrees; and a lid removably fastenable to the tub and including a
gas permeable central portion framed in a border of plastic film
and in sealing engagement with the second flange; and wherein the
medical device is sealable within the tub by the lid and wherein
the tub enables sterilization of the medical device sealingly
contained within the tub by the combined transmission of ultra
violet light through the tub and of disinfectant gas through the
lid.
2. The medical device package of claim 1, wherein the second
outwardly extending flange extends outward a greater distance than
the first outwardly extending flange.
3. The medical device package of claim 1, wherein a vertical
distance from the first outwardly extending flange and the second
outwardly extending flange defines a gap for use of an interior
holding apparatus.
4. The medical device package of claim 1, where in a horizontal
distance from the first outwardly extending flange and the second
outwardly extending flange defining a second gap to provide a
buffer zone when utilizing an automated opening procedure.
5. The medical device package of claim 1, wherein the tub is formed
of high melt flow polycarbonate.
6. The medical device package of claim 1, wherein the tub is formed
of high melt flow copolyester.
7. The medical device package of claim 1, wherein the tub is formed
of methylpentene copolymer.
8. The medical device package of claim 1, wherein the tub further
includes radiused corners to facilitate removal of the tub from a
mold, and prevent the formation of sharp edges.
9. The medical device package of claim 1, wherein the tub further
includes contoured portions to facilitate removal of the tub from a
mold.
10. The medical device package of claim 1, wherein the tub is
unitarily formed.
11. The medical device package of claim 1, wherein the tub
comprises a plastic which transmits light at 254 nanometers for
killing microorganisms.
12. The medical device package of claim 1, wherein the film is
transparent.
13. The medical device package of claim 1, wherein the film and the
central portion overlap.
14. The medical device package of claim 13, wherein the overlap is
disposed inside of the four top walls.
Description
FIELD OF THE INVENTION
The present invention relates to medical device packages. More
particularly, the present invention relates to medical device
packages having a gas permeable lid and a clear plastic tub.
BACKGROUND OF THE INVENTION
Medical devices, such as prefillable syringes and the like are
frequently packaged in multi-unit packages that must be surface
decontaminated prior to introduction into a controlled sterile
environment where the devices are filled with medication or
otherwise further manipulated prior to use, or used in a surgical
procedure.
There are numerous methods used to sterilize the devices within the
packages, such as gas sterilization utilizing ethylene oxide or
steam sterilization. However, different methods, such as
ultraviolet light sterilization, are often used for decontamination
of the surfaces of the packages prior to subsequent use. It would
be desirable to have a medical device package capable of use in a
multitude of sterilization and decontamination techniques and yield
a high level of kill of microorganisms.
A common type of package utilized in the field of medical packaging
is the peel-open package. Such a package commonly comprises a
thermoplastic film that is formed to a desired package shape and a
lid material is then sealed to the plastic film to contain he
packaged product.
The common thermoplastic film packages described above are often
utilized to package individual medical devices, as the film does
not provide sufficient protective characteristics for use in a
multiunit package which may house delicate items. Therefore, there
is a need for a multiunit package, such as a tub, that can
withstand the sterilization and decontamination processes and
provide a sufficient mechanical barrier to prevent damage to the
items held within the package.
The lid material used is commonly a non-woven fiber arranged such
that it has a microporous structure, such as Tyvek.RTM.. The
microporous fiber arrangement allows gas to penetrate but has a
sufficiently small pore size to block the transfer of
microorganisms.
The microporous fiber arranged lid is, therefore, useful in
sterilization techniques utilizing a gas, such as the
aforementioned ethylene oxide and steam sterilization
techniques.
The Tyvek.RTM. lid, however, does not allow the transmission of
ultraviolet light that may be used as a package surface
decontamination technique. Specifically, the heat seal between the
lid and tub cannot be made flush with the edge of the tub flange
due to processing limitations and the potential for Tyvek.RTM.
tearing during peel open if an unsealed lip of Tyvek.RTM. is not
available for initiation of the peeling process. Therefore, there
is a region outside of the heat seal, covered by Tyvek.RTM., which
is not maintained sterile with the contents of the package. This
area can be inadvertently contaminated during, manipulation of the
package, as can the entire external surface of the package.
However, unlike the remainder of the external surface, which can be
directly exposed to ultraviolet light for decontamination, the area
outside of the heat seal is blocked to the ultraviolet light by the
opaque Tyvek.RTM. material on top and opaque tub material
below.
Therefore, it would be desirable to utilize an ultraviolet-light
transmissive plastic tub that can allow transmission of light to
the underside of the heat seal area between the lid and tub to kill
all microorganisms residing therein. Plastics which transmit light
in the ultraviolet range typically transmit an even greater
percentage of incident light in the visible (400-700 nanometer)
range, resulting in a clear appearance.
An advantage of utilizing a clear plastic tub, as opposed to an
opaque one is that it would allow for visual inspection of the
contents of the package to determine if any of the items are
damaged. This aspect offers quality control advantages to a
manufacturer, as well as allow end users to ensure they are not
receiving or using damaged items. Another advantage of utilizing a
clear plastic tub would be the possible use of an automated visual
quality system. For example, a package and its contents may be
imaged and compared to a stored visual image to determine if the
contents of the package are damaged. Such an automated system could
provide a cost savings, as well as an increased quality control
efficiency.
Alternatively, a Tyvek.RTM. lid having an ultraviolet-light
transmitting plastic border that is heat sealed to a plastic tub
would allow for light sterilization of the area between the lid and
tub. Such a lid may be utilized with either a clear plastic tub, or
with an opaque tub and allow for light to penetrate the area around
the heat seal.
Another problem associated with Tyvek.RTM. lids that are known in
the art, is the possibility of the Tyvek.RTM. lid shearing or
tearing when peeled to open the package and thereby generating
unacceptable particulate matter that may contaminate the contents
of the package.
It is known in the art to coat a Tyvek.RTM. lid in an effort to
reduce particulate generation, as well as prevent the lid from
separating or delaminating when the heat seal strength between the
lid and tub is too great. A disadvantage to this coating technique
is that it has the tendency to reduce the pore size of the
Tyvek.RTM. material; thereby preventing the necessary transmission
of gas across the lid material or increasing the cycle time of a
sterilization procedure.
It would be desirable to have a gas permeable uncoated Tyvek.RTM.
lid that has a smooth continuous plastic border that is resistant
to shearing and does not generate particulate matter when peeled
away to access the contents.
A lid with a smooth continuous plastic border would also be
desirable for use with an automated lid removal system, such as a
hot knife or laser cutter that would cut the plastic border inside
of the heat seal region, as an alternative to a peel-open
technique.
SUMMARY OF THE INVENTION
Therefore, it is an object of the present invention to provide a
medical device package which has an ultraviolet-transmissive and
clear plastic tub to allow for visual inspection of the contents,
as well as to allow for the transmission of microorganism killing
light.
It is a further object of the present invention to provide a
medical device package having a clear plastic tub that has
sufficient strength characteristics to hold and protect from damage
the contents of the package.
It is a further object of the present invention to provide a
medical device package having a microporous, gas permeable lid that
has a plastic border to minimize the creation of particulate matter
when opening the package.
It is a further object of the present invention to provide a
medical device package having a microporous, gas permeable lid with
an ultraviolet-transmissive plastic border to facilitate the
transmission of light during a decontamination process.
The present invention meets these objects by providing a medical
device package having a tub having a four sided base from which
four walls extend upwardly at approximately ninety degrees. The
walls terminate at a first flange which extends outwardly at an
angle of approximately ninety degrees from the four walls. The
first flange terminates at four top walls that extend upwardly at
approximately ninety degrees from the flange. The four top walls
terminate at a second outwardly extending flange, which extends at
an angle of approximately ninety degrees from the four top walls.
The tub is formed of an ultraviolet-light transmitting plastic that
is capable of withstanding exposure to gas sterilization and
surface decontamination processes without degradation of the
tub.
The present invention also includes a lid having a gas permeable
central portion and a transparent plastic film attached to the
central portion along its periphery. The plastic film overlaps the
central portion when attached to assure a reliable bond of the two
items. The transparent plastic film has a high shear resistance to
avoid producing particulate matter when an opening force is
applied. The transparent plastic film also allows transmission of
ultraviolet light. These and other features of the present
invention can be best understood from the following specification
and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the medical device package of the
present invention.
FIG. 2 is a sectional view of the medical device package of the
present invention.
FIG. 3 is a plan view of a corner of the medical device package of
the present invention.
FIG. 4 is perspective view of the tub of the present invention.
FIG. 5 is a plan view of the tub of the present invention showing
the contours that facilitate release of the tub from a mold.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
There is shown generally in FIG. 1 at 10 the medical device package
of the present invention. The medical device package 10 includes a
tub 20 and a lid 60. With reference to FIGS. 1 and 4, the tub 20
has a planar base 22 from which four walls 24, 26, 28, 30 extend
upward at approximately ninety degrees. The four walls 24, 26, 28,
30 terminate at an upper end 32 to form a first outwardly extending
flange 34. The first flange intersects the upper end 32 of the
walls at approximately ninety degrees and extends outwardly
therefrom. There are four top walls 38, 40, 42, 44 extending
upwardly at approximately ninety degrees from the outer edge 36 of
the first outwardly extending flange 34. The four top walls 38, 40,
42, and 44 terminate at a second upper end 46 to form a second
outwardly extending flange 48. The second outwardly extending
flange 48 intersects the second upper end 46 at approximately
ninety degrees and extends outwardly therefrom. The second
outwardly extending flange has an upper surface 50 for mounting or
adhering a lid 60 to the tub 20.
The gap 52 defined by the vertical distance between the first
flange 34 and second flange 48 provides an area for use of an
interior holding apparatus. Such an apparatus could hold the
contents, for example syringes, and maintain the spatial
arrangement of the contents of the package. The gap 52 also
provides a depth for an automated opening tool to be utilized
without contacting and possibly damaging the contents of the tub
20.
The horizontal or outward distance between the first flange 34 and
second flange 48 defines a second gap 54. The contents of the tub
20 are contained inside the space 56 defined by the four walls 24,
26, 28, 30 and are inboard of the first flange 34. The gap 54,
similar to the gap 52 defines a buffer zone when utilizing an
automated opening tool such as a hot knife, or laser cutter to
prevent damage of the contents of the tub 20.
The tub 20 is preferably formed of a plastic resin that allows the
transmission of both visible and ultraviolet light. Examples of
suitable materials for visible light transmission only, include
high melt flow polycarbonate and high melt flow copolyester, which
also exhibit good impact strength and overall durability. A
particularly preferred resin of the present invention is
methylpentene copolymer which transmits both visible and
ultraviolet light and provides good mechanical protection of the
contents of the tub. Specifically, the methylpentene copolymer
demonstrates good transmissive properties at the microorganism
killing ultraviolet wavelengths at 254 nanometers.
The tub 20 is preferably formed utilizing an injection molding
process or a reaction injection molding process. In an injection
molding process, the resin is injected into a mold under a
specified temperature and pressure and allowed to cure to form a
solid article.
The tub 20 of the present invention, preferably, has radiused
corners 58 both on its exterior and interior to facilitate removal
of the tub 20 from the mold during manufacture. The radiused
corners 58 also prevent the formation of sharp edges that may cause
damage to the contents of the tub 20, as well as, pose a threat of
possible injury to a person handling the tub 20. The tub 20 may
also include contoured portions 59, as shown in FIGS. 4 and 5, to
facilitate removal of the tub 20 from the mold during
manufacture.
The lid 60 of the present invention comprises a gas permeable
microfiber central portion 62 and a transparent plastic film 64
attached to the central portion 62 along its periphery 66.
The central portion 62 preferably comprises Tyvek.RTM., a
polyolefin microfiber material produced by E.I. Dupont de Nemours
and Company of Wilmington, Del. Even more preferably, the central
portion 62 comprises uncoated Tyvek.RTM. 1073B.
The transparent plastic film 64 is attached along the periphery 66
of the central portion using adhesives, glues or other bonding
agents or may be heat welded. The transparent plastic film 64
should overlap 68 the central portion at least five millimeters to
assure an adequate bonding between the two items.
The width of the transparent film 64 is variable, dependent upon
the application to which it is to be associated. For example, if
the lid 60 is to be removed manually utilizing a peel-away
procedure, a narrow width in the range of 10-20 millimeters may be
utilized. The 10-20 millimeter width would allow sufficient light
to enter to sterilize the area just outside of the heat seal, but
not be excessively wide from an economic perspective. If the lid 60
is to be utilized in an alternate application such as an automated
opening operation, a wider width may be utilized to prevent
possible shearing of the central portion 62, thereby producing
particulate matter. A suitable width for the transparent film 64 is
in the range of 20 to 30 millimeters for an automated
procedure.
The film 64 should allow transmission of light in the ultraviolet
spectrum for surface decontamination procedures. The film 64 should
also have a sufficient shear strength to resist accidental tearing,
but be capable of easy opening utilizing an automated system.
The present invention has been described in accordance with the
relevant legal standards, thus the foregoing description is
exemplary rather than limiting in nature. Variations and
modifications to the disclosed embodiment may become apparent to
those skilled in the art. Accordingly, the scope of legal
protection afforded this invention can only be determined by
studying the following claims.
* * * * *